FDA approves Moderna’s mRNA vaccine for RSV
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Key takeaways:
- Moderna announced the FDA approved its respiratory syncytial virus vaccine, mResvia.
- The approval was granted under a breakthrough therapy designation.
The FDA has approved Moderna's mResvia, a messenger RNA vaccine to protect adults 60 years or older from lower respiratory tract disease caused by respiratory syncytial virus.
“The FDA approval of our second product, mResvia, builds on the strength and versatility of our [messenger RNA] mRNA platform,” Stéphane Bancel, CEO of Moderna, said in a company press release.
“This approval is also the first time an mRNA vaccine has been approved for a disease other than COVID-19,” Bancel said.
According to the release, approval of mResvia was based on the phase 3 clinical trial ConquerRSV, which showed 83.7% efficacy against RSV lower respiratory tract disease at 3.7 months of median follow-up among 37,000 adults aged 60 years or older. Researchers also found no serious safety concerns. Additional long-term analysis showed protection continued against RSV lower respiratory tract disease over 8.6 months median follow-up.
Moderna said mResvia is the only RSV vaccine available in single-dose pre-filled syringes. The company expects to have mResvia available for eligible populations in the United States within the next year.
[Editor's note: A previous version of this story indicated in the headline and first paragraph that the vaccine was newly designated as a breakthrough therapy by the FDA. The vaccine received breakthrough therapy status in 2023.]
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